Background
Bifurcation lesions in coronary arteries are complex to treat with coronary stents, which are not designed for that purpose and can be unproperly deployed. Moreover, devices are constantly ...evolving, and so are angioplasty techniques.
Objectives
The aim of this study was to determine the performances of different stents in the treatment of bifurcation lesions using the re‐proximal optimization technique (rePOT).
Methods
Eleven stent platforms were evaluated: Xience Sierra (Abbott), Xience Alpine (Abbott), Synergy (Boston), Coroflex Isar (Bbraun), Cobra PzF (Celonova), Ultimaster (Terumo), Resolute Integrity (Medtronic), Resolute Onyx (Medtronic), Optimax (Hexacath), Orsiro (Biotronik), and Absorb (Abbott). Stents were deployed in a silicone fractal bifurcation model using the rePOT. Micro‐computed tomography was performed to assess side branch ostium coverage and strut malapposition, as well as the effect of rePOT on stent cell area.
Results
Our study showed significant differences between stent platforms regarding side branch ostium coverage (p = .002). The Synergy and Cobra PzF stents were the most performant devices to avoid ostium coverage. Strut malapposition varied significantly between devices (p = .008) but the percentage of malapposed struts was relatively low. Significant differences were observed between stents regarding the cell area before (p = .002) and also after rePOT (p = .003), and the increase in cell area caused by rePOT varied considerably between devices (p = .08).
Conclusion
This study highlighted significant differences in the performances of stent platforms deployed in a fractal bifurcation model using rePOT, with a variable impact of the procedure on stent cell area.
Pre-stenting of the right ventricular outflow tract (RVOT) is commonly performed before percutaneous pulmonary valve implantation (PPVI), to relieve obstruction, prevent valved stent fractures, and ...provide a landing zone. This study aimed to evaluate the biomechanical characteristics of the stents currently used to perform pre-stenting of the RVOT.
We assessed five commercially available stents: Cheatham-Platinum Stent ("CP Stent"), AndraStent XL, AndraStent XXL, Optimus XL, and Optimus XXL. Following stent deployment at nominal pressure, radial and longitudinal elastic recoils and radial resistance were measured. The bending stiffness of the stents crimped onto the balloons was also evaluated.
Three samples were tested for each stent. Our study showed no significant difference between the stent platforms in terms of radial elastic recoil, which was relatively low (< 10%). The longitudinal elastic recoil was also low for all the devices (< 5%). Significant differences were observed in radial resistance (P < 0.001). CP Stent and AndraStent XL exhibited the highest radial resistances. The bending stiffnesses of the stents crimped on their balloons were significantly different (P < 0.00001). Optimus XL and XXL were more flexible than the other stents.
This study highlights the significant differences between the stents currently used in RVOT pre-stenting. Stents with good radial resistance are preferred, especially for calcified vessels, and flexibility is crucial for tortuous vessels. We proposed an algorithm for selecting the most suitable stent according to the need for radial force and flexibility, which will help inform clinicians considering RVOT revalvulation.
The purpose of this study was to evaluate the percentage of coronary angiography that can be securely avoided by the interpretation of coronary arteries on pre transcatheter aortic valve implantation ...CT (TAVI-CT), using CT images obtained with deep-learning reconstruction and motion correction algorithms.
All consecutive patients who underwent TAVI-CT and coronary angiography, from December 2021 to July 2022 were screened for inclusion in the study. Patients who had previous coronary artery revascularization or who did not undergo TAVI were excluded. All TAVI-CT examinations were obtained using deep-learning reconstruction and motion correction algorithms. On TAVI-CT examinations, quality and stenosis of coronary artery were analyzed retrospectively. When insufficient image quality and/or when diagnosis or doubt of one significant coronary artery stenosis, patients were considered as having possible coronary artery stenosis. The results of coronary angiography were used as the standard of reference for significant CAS.
A total of 206 patients (92 men; mean age, 80.6 years) were included; of these 27/206 (13%) had significant coronary artery stenosis on coronary angiography and were referred for potential revascularization. Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of TAVI-CT to identify patients requiring coronary artery revascularization was 100% (95% confidence interval CI: 87.2-100%), 100% (95% CI: 96.3-100%), 54% (95% CI: 46.6-61.6), 25% (95% CI: 17.0-34.0%) and 60% (95% CI: 53.1-66.9%) respectively. Intra- and inter observer variability was substantial agreement for quality and decision to recommend coronary angiography. Mean reading time was 2 ± 1.2 (standard deviation) min (range: 1-5 min). Overall, TAVI-CT could potentially rule out indication for revascularization for 97 patients (47%).
Analysis of coronary artery on TAVI-CT using deep-learning reconstruction and motion correction algorithms can potentially safely avoid coronary angiography in 47% of patients.
Transcatheter aortic-valve replacement (TAVR) reduces mortality and improves quality of life in patients with severe aortic valve stenosis. One third of patients have no benefit one year after TAVR. ...Sarcopenia, an age-related loss of skeletal muscle mass, is associated with increased physical disability and mortality. The main purpose was to evaluate the impact of severe sarcopenia on rehospitalization one year after TAVR in older patients.
All patients aged ≥75 referred for a TAVR in 2018 were included. Severe sarcopenia was defined by a loss of skeletal muscle mass defined on CT-scan measurement associated with a gait speed ≤0.8m/s. The main outcome was rehospitalization one year after TAVR.
Median age of the 182 included patients was 84, and 35% had an unplanned hospitalization at one year. Severe sarcopenia was diagnosed in 9 patients (4.9%). Univariable analysis showed that gait speed was a factor associated with readmission HR=0.32, 95% CI (0.10-0.97), p=0.04 but not severe sarcopenia. In multivariable analysis, only diabetes was significantly associated with rehospitalization HR=2.06, 95% CI (1.11-3.84), p=0.02. Prevalence of severe sarcopenia varied according to different thresholds of skeletal muscle mass on CT-scan.
Even though severe sarcopenia was not correlated with rehospitalization and mortality at one year after TAVR, our results emphasize the changes in the prevalence according to cutoff used. It highlights the need to define standardized methods and international threshold for sarcopenia diagnosis by CT-scan measurements, in general population and for patients with valvular heart disease.
Objectives
Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or ...deteriorated bioprosthesis.
Background
Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints.
Methods
The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations.
Results
From 2016 to 2021, 102 patients (median age: 81 74;84 years, 61% female, Euroscore II 11.0% 7.8;16.0) undergoing valve‐in‐valve (ViV; n = 89) or valve‐in‐ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow‐up (6–12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow‐up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08–5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456).
Conclusions
This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.
Transcatheter aortic valve replacement (TAVR) has revolutionized the prognosis of inoperable patients with severe aortic valve stenosis. Yet, the implantation of expensive prostheses in patients with ...comorbidities may be questionable in an era when healthcare costs are becoming a major concern.
The objective of this study was to assess whether the TAVR procedure is profitable in a high-volume French hospital.
Consecutive patients eligible for transfemoral TAVR using the SAPIEN bioprostheses (Edwards Lifesciences, Irvine, CA, USA) were included retrospectively in this single-centre study between September 2014 and December 2015. Three medicoeconomic severity-level subgroups were considered. The primary clinical endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary composite endpoints included major adverse events within 30 days and breakdown of costs.
Overall, 189 patients were included in the analysis. Three patients died (two from non-cardiac causes) within 30 days of the procedure. The mean hospital cost was €27,530±3814 per patient, and the mean hospital income was €30,313±2681 per patient (P<0.001), resulting in a significant profit of €2783±1743 per patient. The total estimated profit was €525,000 for the whole study period. The largest benefits were observed for patients assigned to the lowest severity level. The price of the bioprosthesis represented 71% of the total costs.
The TAVR procedure performed in carefully selected patients was profitable for the academic centre, regardless of the level of severity assigned to the patients.
Le remplacement valvulaire aortique percutané (TAVR) a révolutionné le pronostic des patients non opérables présentant une sténose aortique sévère. Le coût des prothèses implantées chez des patients comorbides pourrait être discutable à l’époque où les enjeux médico-économiques constituent une problématique majeure.
L’objectif de cette étude était de déterminer la rentabilité du TAVR dans un hôpital français à grand volume d’activité.
Tous les patients consécutifs éligibles au TAVR transfémoral avec une bioprothèse SAPIEN (SAPIEN-XT ou SAPIEN 3 ; Edwards Lifesciences, Irvine, CA, État-Unis) entre septembre 2014 et décembre 2015 étaient inclus rétrospectivement dans cette étude monocentrique. Trois sous-groupes étaient constitués, selon le niveau de sévérité médico-économique. Le critère de jugement principal était la différence entre les coûts et les remboursements pour chaque séjour de patient. Les critères secondaires étudiaient les événements indésirables graves à 30jours et la répartition des coûts.
Cent quatre vingt-neuf patients étaient inclus dans l’analyse. Au trentième jour, 3 patients étaient décédés (2 de causes non cardiaques). Le coût moyen s’élevait à €27 530±3814 pour un remboursement à €30 313±2681 par patient (p<0,001). Le critère de jugement principal démontrait un bénéfice significatif de €2783±1743 par patient pour un bénéfice total de €525 000 sur la période évaluée. Les patients présentant le plus faible niveau de sévérité généraient les bénéfices les plus importants. Le prix de la bioprothèse représentait 71 % du coût total.
Le TAVR transfémoral chez des patients sélectionnés est rentable pour le centre implanteur, indépendamment du niveau de sévérité du patient.
After transcatheter aortic valve replacement (TAVR), cardiovascular and non-cardiovascular comorbidities may offset the survival benefit from the procedure.
We aimed to describe the relationships ...between that benefit and patient comorbidities.
The study pooled two European cohorts of patients with severe aortic stenosis (AS-pooled): one with patients who underwent (cohort of AS patients treated by TAVR, n=233) and another with patients who did not undergo TAVR (cohort of AS patients treated medically; n=291). The investigators collected the following: calcification prognostic impact (CAPRI) and Charlson scores for cardiovascular and non-cardiovascular comorbidities, activities of daily living (ADL)/instrumental activities of daily living (IADL) scores for frailty as well as routine Society of Thoracic Surgeons (STS) score and Logistic Euroscore.
Unlike ADL/IADL scores, CAPRI and Charlson scores were found to be independent predictors of 1-year all-cause death in the AS-pooled cohort, with and without adjustment for STS score or Logistic Euroscore; they were thus retained to define a three-level prognostic scale (good, intermediate, and poor). The survival benefit from TAVR—vs. no TAVR—was stratified according to these three prognosis categories. The beneficial effect of TAVR on 1-year all-cause death was significant in patients with good and intermediate prognosis, hazard ratio (95% confidence interval): 0.36 (0.18; 0.72) and 0.32 (0.15; 0.67). That effect was reduced and not statistically significant in patient with poor prognosis 0.65 (0.22; 1.88).
The study showed that, beyond a given comorbidity burden (as assessed by CAPRI and Charlson scores), the probability of death within a year was high and poorly reduced by TAVR. This indicates the futility of TAVR in patients in the poor prognosis category.
Background and Aim
The mortality rate of patients with post‐myocardial infarction (MI) ventricular septal defects (VSDs) is high, and the benefit of surgery is unclear. We aimed to investigate the ...management and outcomes of post‐MI VSD over a 10‐year period in a large cohort.
Methods
Data of patients with post‐MI VSD admitted in three French university hospitals from 2008 to 2019 were examined. The characteristics of those who underwent surgery were compared with those who received medical treatment. Mortality risk factors, survival curves, and outcomes at 30 days and 1 year after treatment were determined.
Results
Of the 92 patients whose data were examined, 50 underwent surgery and 42 received exclusive medical treatment. All patients were critically ill. Overall, 76.1% of patients received inotropic support, and 63% received mechanical ventilation. Circulatory assistance, mainly via intra‐aortic balloon pump and extra‐corporeal membrane oxygenation, was provided to 46.7% patients, with 14.1% requiring a second assistance. The median time to surgery was 4 days. At 1 year, mortality was 46% in those who underwent surgery and 83.3% in those treated medically (p < .001). Survival curves at 1 and 3 months showed major differences, and the survival rate showed little change 30 days after treatment. Cardiogenic shock and cardiac arrest emerged as risk factors for mortality.
Conclusions
In our retrospective, multicenter study, the mortality resulting from post‐MI VSD did not seem to improve over the last decade. Although surgery carried considerable risks, it improved survival.